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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K202689
Device Name Dentilube Spray
Applicant
Oxy2plus, LLC
4120 Rosemead Blvd.
Rosemead,  CA  91770
Applicant Contact Chun nan Lin
Correspondent
Oxy2plus, LLC
4120 Rosemead Blvd.
Rosemead,  CA  91770
Correspondent Contact Chun nan Lin
Classification Product Code
LFD  
Date Received09/15/2020
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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